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HEATmarker® Time-Temperature Indicators: CT3

FDA UDI

Class II (US FDA UDI)

by Temptime Corporation

Identity

Trade Name
HEATmarker® Time-Temperature Indicators: CT3 FDA UDI
Generic Name
Medical product temperature point indicator, thermochemical FDA UDI
Device Name
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 91 days at 22.5°C. FDA UDI
Model / Reference
CT3 FDA UDI
Description
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 91 days at 22.5°C. FDA UDI

Identifiers

Primary DI / UDI-DI
00852282007075 FDA UDI
FDA Product Code
JOJ FDA UDI
GMDN Term
Medical product temperature point indicator, thermochemical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.2800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Medical product temperature point indicator, thermochemical

HEATmarker® Time-Temperature Indicators: CT3 by Temptime Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Medical product temperature point indicator, thermochemical.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Temptime Corporation

Sources (1)

  • FDA UDI 8fed2140-1c89-4ea0-b3f9-3c997ff34362 35 fields · synced May 30, 2026